- Location
- Paris, France
- Type
- Full-time
- Department
- IT
- Seniority
- Entry
- Experience
- 1+ years
- Education
- Bachelor
- Source
- Workday
Description
Country Associate Submissions Representative (Regulatory & Start-Up Specialist)
Homebased
France
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.
Job Summary
The Site Activation Specialist is responsible for coordinating and executing site start-up and activation activities for clinical research studies in accordance with applicable regulations, SOPs, project requirements, and timelines. The role serves as a key point of contact for investigative sites and project teams, ensuring the timely preparation, review, and tracking of regulatory and essential study documents.
Key Responsibilities
Act as the primary contact for assigned investigative sites and project stakeholders during site activation activities.
Perform site start-up and activation activities in compliance with applicable regulations, SOPs, and work instructions.
Prepare, review, and maintain site regulatory documentation, ensuring accuracy and completeness.
Track approvals and execution of regulatory, ethics, informed consent, and study-related documents to meet project timelines.
Maintain project information in internal systems, databases, and tracking tools.
Monitor site performance metrics and provide updates to management and project teams.
Support project planning, timeline management, and implementation of contingency plans when required.
Perform quality control reviews of site documentation.
Provide local regulatory and site activation expertise to project teams and stakeholders.
Qualifications
Bachelor's degree in Life Sciences, Health Sciences, or a related field.
Minimum 1 year of clinical research experience.
Knowledge of contract amendments and updating of ICFs beneficial.
Knowledge of clinical research regulations, Good Clinical Practice (GCP), and site activation processes.
Strong organizational, communication, and relationship management skills.
Ability to manage multiple priorities and meet project deadlines.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.